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Clinical Trial Details

Trial ID: L3955
Source ID: NCT05790681
Associated Drug: Insulin Icodec
Title: A Study to Test How New Long-acting Insulin (Insulin Icodec) Works in the Body of Children and Teenagers
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Insulin icodec
Outcome Measures: Primary: Area under the serum insulin icodec concentration-time curve after a single dose (AUCIco,0-inf,SD), Measured in picomoles\*hours per liter (pmol\*h/L)., From 0 hours until infinity after trial product administration (day 1)|Maximum observed serum insulin icodec concentration after a single dose (Cmax,Ico,SD), Measured in picomoles per liter (pmol/L)., From 0 hours until last measurement time after trial product administration (day 1)|Time to maximum observed serum insulin icodec concentration after a single dose (tmax,Ico,SD), Measured in hours., From 0 hours until last measurement time after trial product administration (day 1) | Secondary: Model-based maximum serum insulin icodec concentration during one dosing interval at steady state (Cmax,Ico,SS,model), Measured in pmol/L., From 0 to 168 hours after trial product administration|Model-based area under the serum insulin icodec concentration-time curve during one dosing interval at steady state (AUC,Ico,τ,SS,model), Measured in pmol\*h/L., From 0 to 168 hours after trial product administration
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE1
Enrollment: 18
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-04-25
Completion Date: 2024-02-08
Results First Posted:
Last Update Posted: 2024-04-18
Locations: Children's Hosp-Los Angeles, Los Angeles, California, 90027, United States|Yale University, New Haven, Connecticut, 06511, United States|Nemours Chld Clnc Jacksonville, Jacksonville, Florida, 32207, United States|Pennington Biom Res Ctr, Baton Rouge, Louisiana, 70808, United States|John Hopkins Univ Hosp, Baltimore, Maryland, 21287, United States|UBMD Peds-Div of Endo/Diabetes, Buffalo, New York, 14203, United States|Cincinnati Child's Hsp Med Ctr, Cincinnati, Ohio, 45229, United States|Nationwide Children's Hospital, Columbus, Ohio, 43205, United States|University of Virginia, Charlottesville, Virginia, 22908, United States
URL: https://clinicaltrials.gov/show/NCT05790681